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    Summary
    EudraCT Number:2019-003992-21
    Sponsor's Protocol Code Number:IM027-040
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-30
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-003992-21
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis
    Studio di Fase 2 multicentrico, randomizzato, in doppio cieco, controllato con placebo volto a valutare l’efficacia, la sicurezza e la tollerabilità di BMS-986278 nei partecipanti affetti da fibrosi polmonare
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-
    986278 in Participants with Lung Fibrosis
    Studio volto a valutare l’efficacia, la sicurezza e la tollerabilità di BMS-986278 nei partecipanti affetti da fibrosi polmonare
    A.3.2Name or abbreviated title of the trial where available
    Phase 2 Study of the Efficacy and Safety of BMS-986278 in Pulmonary Fibrosis
    Studio di Fase 2 sull’efficacia e sulla sicurezza di BMS-986278 nella fibrosi polmonare
    A.4.1Sponsor's protocol code numberIM027-040
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1241-6174
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointHead of the GSM-CT
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance, Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.4Telephone number000000
    B.5.5Fax number000000
    B.5.6E-mailclinical.trials@bms.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBMS-986278
    D.3.2Product code [BMS-986278]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLPA1
    D.3.9.2Current sponsor codeBMS-986278
    D.3.9.3Other descriptive nameBMS-986278
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBMS-986278
    D.3.2Product code [BMS-986278]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLPA1
    D.3.9.2Current sponsor codeBMS-986278
    D.3.9.3Other descriptive nameBMS-986278
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary Fibrosis
    Fibrosi Polmonare
    E.1.1.1Medical condition in easily understood language
    Pulmonary Fibrosis
    Fibrosi Polmonare
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10037383
    E.1.2Term Pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the rate of change in percent predicted forced vital capacity (ppFVC)
    Valutare il tasso di variazione della capacità vitale forzata prevista in percentuale (ppFVC)
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of BMS-986278
    - To evaluate the rate of change in ppFVC;
    - To evaluate the effect of treatment with BMS-986278 on clinical assessments;
    - To characterize the PK of BMS-986278 in IPF and PF-ILD participants.
    - valutare la sicurezza e la tollerabilità di BMS-986278
    - valutare il tasso di variazione in ppFVC;
    - valutare l'effetto del trattamento con BMS-986278 sulle valutazioni cliniche;
    - caratterizzare la Farmacocinetica di BMS-986278 nei partecipanti IPF e PF-ILD.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenetics
    Version: Revised Protocol 2
    Date: 25/06/2020
    Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis
    Objectives: - Additional Research Additional Research is optional for all study participants, except where retention and/or collection is prohibited by local laws or regulations, ethics committees, or institutional requirements. This collection for additional research is intended to expand the translational R&D capability at Bristol-Myers Squibb, and will support as yet undefined research aims that will advance our understanding of disease and options for treatment. It may also be used to support health authority requests for analysis, and advancement of pharmacodiagnostic development to better target drugs to the right patients. This may also include genetic/genomic exploration aimed at exploring disease pathways, progression and response to treatment etc.

    Pharmacogenomics
    Version: Revised Protocol 2
    Date: 25/06/2020
    Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis
    Objectives: - Additional Research Additional Research is optional for all study participants, except where retention and/or collection is prohibited by local laws or regulations, ethics committees, or institutional requirements. This collection for additional research is intended to expand the translational R&D capability at Bristol-Myers Squibb, and will support as yet undefined research aims that will advance our understanding of disease and options for treatment. It may also be used to support health authority requests for analysis, and advancement of pharmacodiagnostic development to better target drugs to the right patients. This may also include genetic/genomic exploration aimed at exploring disease pathways, progression and response to treatment etc.

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Intensive PK Substudy:
    An intensive PK substudy will be conducted in approximately 25% of IPF participants in each dose group, for which serial PK samples, ECGs, and BP and HR measurements will be collected (see details in Table 6 of the protocol).
    In addition to assessing concentrations of BMS-986278 and the BMT-323719 metabolite, additional PK samples will be collected predose and will be used to analyze for concentrations of pirfenidone or nintedanib by validated assays in participants that receive these medications.
    Key PK parameters to be assessed in the intensive PK sampling study include: Cmax, Tmax, AUC(0-8), Ctrough.
    Individual participant PK parameter values will be derived by noncompartmental methods by a validated PK analysis program.
    Concentration data from this study may be combined with data from the Phase 1 studies in healthy subjects to further characterize the PK of BMS-986278 using population PK analysis.
    The relationship between measures of exposure and endpoints for efficacy and safety may also be explored using model-based exposureresponse analysis. Results of these analyses will be reported separately.

    Farmacogenetica
    Versione: Revised Protocol 2
    Data: 25/06/2020
    Titolo: Studio di Fase 2 multicentrico, randomizzato, in doppio cieco, controllato con placebo volto a valutare l’efficacia, la sicurezza e la tollerabilità di BMS-986278 nei partecipanti affetti da fibrosi polmonare
    Obiettivi: si veda la sezione 8.6.1 Additional Research Collection La ricerca addizionale è facoltativa per tutti i partecipanti allo studio, tranne nei casi in cui la conservazione e/o la raccolta è vietata dalle leggi e dai regolamenti locali, dai comitati etici, o requisiti istituzionali. Questa raccolta per ulteriori ricerche ha lo scopo di espandere la capacità di ricerca e sviluppo traslazionale presso Bristol-Myers Squibb e sosterrà obiettivi di ricerca ancora non definiti che miglioreranno la nostra comprensione della malattia e opzioni diverse per il trattamento. Può anche essere usato per sostenere richieste di autorità per analisi e avanzamento dello sviluppo della farmacodiagnostica per meglio indirizzare i farmaci ai pazienti più indicati. Questo potrebbe anche includere l'esplorazione genetica / genomica volta ad esplorare i percorsi della malattia, la sua progressione, la risposta al trattamento ecc

    Farmacogenomica
    Versione: Revised Protocol 2
    Data: 25/06/2020
    Titolo: Studio di Fase 2 multicentrico, randomizzato, in doppio cieco, controllato con placebo volto a valutare l’efficacia, la sicurezza e la tollerabilità di BMS-986278 nei partecipanti affetti da fibrosi polmonare
    Obiettivi: si veda la sezione 8.6.1 Additional Research Collection La ricerca addizionale è facoltativa per tutti i partecipanti allo studio, tranne nei casi in cui la conservazione e/o la raccolta è vietata dalle leggi e dai regolamenti locali, dai comitati etici, o requisiti istituzionali. Questa raccolta per ulteriori ricerche ha lo scopo di espandere la capacità di ricerca e sviluppo traslazionale presso Bristol-Myers Squibb e sosterrà obiettivi di ricerca ancora non definiti che miglioreranno la nostra comprensione della malattia e opzioni diverse per il trattamento. Può anche essere usato per sostenere richieste di autorità per analisi e avanzamento dello sviluppo della farmacodiagnostica per meglio indirizzare i farmaci ai pazienti più indicati. Questo potrebbe anche includere l'esplorazione genetica / genomica volta ad esplorare i percorsi della malattia, la sua progressione, la risposta al trattamento ecc

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio Intensivo di Farmacocinetica
    Verrà condotto un sottostudio intensivo di PK sul 25% circa dei partecipanti nella coorte IPF in ciascun gruppo di dosaggio, per il quale verranno raccolti campioni seriali di PK, ECG e misurazioni Pressione Sanguigna e Frequenza Cardiaca (vedere i dettagli nella Tabella 6 del protocollo).
    Oltre a valutare le concentrazioni di BMS-986278 e del metabolita BMT-323719, ulteriori campioni di PK saranno raccolti prima dell’assunzione del farmaco e saranno utilizzati per analizzare le concentrazioni di pirfenidone o nintedanib mediante test validati nei partecipanti che ricevono questi farmaci.
    Parametri chiave della PK da valutare nello studio intensivo di PK includono: Cmax, Tmax, AUC (0-8), Ctrough.
    I valori dei parametri PK dei singoli partecipanti verranno derivati da metodi non compartimentali mediante un programma di analisi PK convalidato.
    I dati di concentrazione di questo studio possono essere combinati con i dati degli studi di Fase 1 in soggetti sani per caratterizzare ulteriormente la PK di BMS-986278 usando l'analisi della PK di popolazione.
    La relazione tra misure di esposizione e gli endpoint per l'efficacia e la sicurezza possono anche essere esplorate utilizzando un modello base di analisi esposizione-risposta. I risultati di queste analisi saranno riportati separatamente.
    E.3Principal inclusion criteria
    For the idiopathic pulmonary fibrosis (IPF) Cohort:
    - Diagnosis of IPF within 7 years
    - Female and males = 40 years of age

    For the progressive fibrotic interstitial lung disease (PF-ILD) Cohort:
    - Evidence of progressive ILD within the 24 months before screening
    - Female and male = 21 years of age.
    Coorte con Fibrosi Polmonare Idiopatica (FPI):
    - Diagnosi di IPF entro 7 anni
    - Maschi e Femmine età = 40

    Coorte con malattia polmonare interstiziale fibrotica progressiva diversa dall’IPF (PFILD):
    -Evidenza di ILD progressiva entro 24 mesi dallo screening
    - Maschi e Femmine età = 21
    E.4Principal exclusion criteria
    _Women who are of childbearing potential
    _Active Smokers
    _Patients with current malignancy
    _History of allergy to BMS-986278 or related compounds
    - Donne in età fertile
    - Attivi fumatori
    - Pazienti con tumori in corso
    - Storia di allergia a BMS-986278 o composti correlati
    E.5 End points
    E.5.1Primary end point(s)
    Rate of change in ppFVC (%) from baseline to Week 26 in IPF participants.
    Tasso di variazione in ppFVC (%) dal basale alla settimana 26 nei partecipanti IPF
    E.5.1.1Timepoint(s) of evaluation of this end point
    W26
    SettImana 26
    E.5.2Secondary end point(s)
    _AEs, SAEs, AEs leading to early discontinuation of study treatment,
    Treatment-emergent deaths, Clinical laboratory findings and ECGs, Vital
    signs, Physical exam findings up to 26 weeks;
    _Rate of change in ppFVC (%) from baseline to Week 26 in PF-ILD
    participants;
    _Proportion of participants with = 10% absolute decline in ppFVC (%) at
    Weeks 4, 8, 12, 16, and 26;
    _Time to first = 10% absolute decline in ppFVC (%) up to 26 weeks;
    _Absolute change in FVC (mL) from baseline up to Week 26;
    _Absolute change in ppFVC (%) from baseline up to Week 26;
    _Absolute change in DLCO SB (mL/min/mmHg) (corrected for
    hemoglobin) from baseline to Week 26;
    _Absolute change in ppDLCO SB (%) (corrected for hemoglobin) from
    baseline to Week 26;
    _Change in walking endurance/distance from baseline at Week 26 as
    measured using the 6MWT;
    _Proportion of participants with acute acerbations of lung fibrosis up to
    week 26
    _Cmax, Tmax, and AUC(0-8) on Day 1 and Week 4 and Ctrough on Week
    4 and Week 12 of intensive PK substudy
    - Eventi avversi, eventi avversi seri, eventi avversi che portano alla sospensione precoce del trattamento in studio, morti emergenti dal trattamento, risultati anomali di laboratorio ed anomalie negli esami negli ECG, segni vitali, esame obiettivo fino a 26 settimane;
    - Tasso di variazione in ppFVC (%) dal basale alla settimana 26 nei partecipanti PF-ILD;
    - Proporzione di partecipanti con un declino assoluto = 10% in ppFVC (%) alle Settimane 4, 8, 12, 16 e 26;
    - Tempo al primo declino assoluto = 10% in ppFVC (%) fino a 26 settimane;
    - Variazione assoluta di FVC (mL) dal basale alla settimana 26;
    - Variazione assoluta in ppFVC (%) dal basale alla settimana 26;
    - Modifica assoluta in DLCO SB (mL / min / mmHg) (corretta per emoglobina) dal basale alla settimana 26;
    - Variazione assoluta in ppDLCO SB (%) (corretta per l'emoglobina) dal basale alla settimana 26;
    - Cambiamento nella resistenza alla deambulazione / distanza percorsa dal basale alla Settimana 26 misurato usando il 6MWT;
    - Proporzione di partecipanti con acerbazioni acute della fibrosi polmonare fino alla settimana 26
    - Cmax, Tmax e AUC (0-8) al Giorno 1 e alla Settimana 4 e Ctrough alla Settimana 4 e alla Settimana 12 del sottostudio intensivo PK
    E.5.2.1Timepoint(s) of evaluation of this end point
    _all through the duration of the study;
    _W26;
    _Weeks 4, 8, 12, 16, and 26 or W26;
    _day 1 or W4 or W12
    - Per tutta la durata dello studio;
    - W26;
    - Settimane 4, 8, 12, 16 e 26 o Settmiana 26;
    - Giorno 1 o Settimana 4 o Settimana 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    Chile
    Israel
    Japan
    Korea, Republic of
    Mexico
    Taiwan
    United States
    Belgium
    France
    Germany
    Italy
    Spain
    United Kingdom
    Argentina
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The last day of the main study will occur when the last participant has
    completed the follow-up visit (28 ± 7 days after the Week 26 visit).
    Participants will be considered to have completed the main study if
    they complete 26 weeks of evaluation.
    The last participant visit of the OTE is defined as the last visit or
    scheduled procedure for the last participant, whichever occurs last.
    This last participant visit will be the last visit for the entire study.
    La fine studio principale si verificherà quando ultimo partecip.avrà completato visita di FU(28 ± 7 giorni dopo visita settim.26).
    Si considererà che i partecipanti abbiano completato studio princ se completano valutazioni della settim.26.
    L'ultima visita per il partecipante dell'OTE è definita come l'ultima visita, o procedura programmata per l'ultimo partecipante, a seconda di quale si verifica per ultima.
    Quest'ultima visita per il partecipante sarà l'ultima visita dell'intero studio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days19
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 270
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 108
    F.4.2.2In the whole clinical trial 360
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nessuno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-24
    P. End of Trial
    P.End of Trial StatusOngoing
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